BI-NATIONAL COLORECTAL CANCER AUDIT

BI-NATIONAL COLORECTAL CANCER AUDIT

THIS PUBLICATION WAS PRODUCED ON BEHALF OF THE BI-NATIONAL COLORECTAL CANCER AUDIT (BCCA). SUGGESTED CITATION: Professor Alexander Heriot, Professor Cameron Platell, Associate Professor Chris Byrne, Professor Pierre Chapuis, Mr Mark Doudle, Associate Professor Paul McMurrick, Dr Elizabeth Murphy, Mr Mark Thompson-Fawcett, Ms Angela Brennan, Professor Chris Reid, Ms Michaela O Regan, Ms Julie Wood, Mrs Kerri Buczynskyj. The Bi-National Colorectal Cancer Audit Report 218, May 218, pages 64. ANY ENQUIRES REGARDING THIS PUBLICATION SHOULD BE DIRECTED TO: BCCA Project Manager Suite 6, 9 Church Street Hawthorn VIC 3122 Phone: +61 3 9853 813 Email: bcca@cssanz.org Website: bcca.registry.org.au The contents of this report may not be published or used without permission. 2 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

CONTENTS Acknowledgements... 4 Foreword... 5 Executive Summary... 6 Message from Steering Committee Chair... 8 What is BCCA... 9 Where are we now?... 1 BCCA Governance... 11 Data Access... 12 Research... 13 Clinical Quality... 15 BCCA Methodology... 17 Data Handling... 18 Data Completion... 19 Data Submission... 19 Participating Sites... 2 List of Figures... 23 List of Tables... 24 Patient Characteristics... 25 FOBT Diagnosis and Bowel Screening Programmes.. 28 Surgical Care... 31 Overall Colorectal Cancer... 32 Length of Hospital Stay... 38 Operative Approach... 43 Colon Cancer... 45 Rectal Cancer... 5 Adjuvant Therapy... 57 Future Directions... 58 BCCA Participation... 59 BCCA Personnel... 6 Glossary... 61 References... 62 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 3

ACKNOWLEDGEMENTS BCCA is funded by a combination of sources including in-kind donations from the Colorectal Surgical Society of Australia and New Zealand (CSSANZ), the Royal Australasian College of Surgeons (RACS) Colon and Rectal Surgery Section and annual subscription fees paid by surgeons. Education and reporting initiatives are supported by Medtronic. We also acknowledge funding from Johnson & Johnson and the RACS Research, Audit and Academic Surgery Division who supported BCCA in initial years. Expert advice was provided by Arul Earnest from the Registry Sciences Unit, Department of Epidemiology and Preventive Medicine, Monash University. Development and ongoing database support is provided by the Clinical Data Management Systems (CDMS) team, E-Solutions, Monash University. This report would not have been possible without the efforts of surgeons, site managers and other relevant staff who have contributed data to BCCA. The management committee (BCCA Operations Committee) is also gratefully acknowledged and details of personnel can be found on page 6. BCCA is appreciative of support from CSSANZ General Manager, Liz Neilson, and the CSSANZ for their ongoing support. 4 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

FOREWORD Colorectal cancer remains a major healthcare concern within the western world and Australia and New Zealand continue to have among the highest rates regarding both diagnosis and death. The Bi-National Colorectal Cancer Audit (BCCA) is able to promote and enable best practice in colorectal cancer surgery, by collecting relevant, standardised clinical data and providing meaningful feedback to the public, clinicians and healthcare providers in both Australia and New Zealand. As a Clinical Quality Registry (CQR) it is ideally positioned to recognise areas pertinent to patient safety, establish relevant benchmarks, and identify institutions that may be performing outside the common bounds of the larger group. Since its inception in 27, the BCCA dataset has continued to grow with increased representation from both metropolitan and rural institutions. Both general surgeons and colorectal specialists contribute to the BCCA dataset, allowing for a more representative snapshot of colorectal cancer care, and the establishment of relevant benchmarks. The BCCA reports patient outcomes on over 22, patients with colorectal cancer across Australia and New Zealand between 27 and 217, providing key insights into the quality of care received in both countries. The introduction of a template to facilitate data entry from existing databases is a great step forward and is reflected in the increase in case submission to the database. The ANZTBCRS (Australian and New Zealand Training Board in Colon and Rectal Surgery) units will all be contributing to the BCCA from 218 and it is encouraging to see increasing uptake. I would like to congratulate all contributing surgeons and their teams for their ongoing support of BCCA, and the authors for their hard work in producing yet another outstanding report. James Keck President Colorectal Surgical Society of Australia and New Zealand THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 5

EXECUTIVE SUMMARY Information on over 23,1 patients with colorectal cancer across Australia and New Zealand has been collected over the period from 27 to 217, with over 2,6 patients entered in 217. This is 5,4 patients more than the 217 annual report, a result of a number of historic datasets, including the Otago Clinical Audit dataset from New Zealand and components of the ACCORD (Australian Comprehensive Cancer Outcomes and Research Database) dataset from Victoria, being uploaded to the BCCA over the last year. The new patients from 217 represent approximately 13% of the new colorectal cancer patients that would have presented over this period across both countries. This number will increase in the 219 report as all the ANZTBCRS (Australian and New Zealand Training Board in Colon and Rectal Surgery) units across Australasia will be submitting data from 218. The vast majority (92%) of patients are aged over 5 years at presentation, however the under 5 years age group made up 8% of new presentations across the 11- year period (n=1,877). This underscores the importance of ensuring that the message that colorectal cancer is not confined to the elderly is publicised. A third of the patients (37%) were ASA (American Society of Anaesthesiologists Classification) three or greater, signifying that these patients have significant existing co-morbidities, thus increasing the potential for postoperative complications. Approximately one third of tumours (3.5%) are in the rectum, with 12% of patients presenting with metastatic disease. The proportion of patients diagnosed following FOBT (Faecal Occult Blood Test) remains fairly steady however this has increased to 14% in 217. There has been and there is an ongoing staged expansion of the national screening programs across Australia and New Zealand. The age distribution of patients identified is consistent with the age distribution of the screening program as would be expected. It is encouraging however that there does appear to be a stage shift in patients diagnosed through the national screening programs with a higher proportion of Stage I patients. Overall hospital mortality for patients with colorectal cancer remains steady over time at under 2% but is strongly influenced by the urgency of admission. Mortality ranges from 5% to 3% to 1% as cases present as an emergency (6%), an urgent (7%), or as an elective (87%) case respectively. Mortality reduces as reported case load increases, and can be risk adjusted for age, ASA, urgency of admission, complications, location of tumour in the rectum, laparoscopic entry and surgical procedure. There were no units that were outliers for mortality on risk adjusted data. The return to theatre rate was 6.4%, reducing to 5.9% when risk adjusted. Overall complication rate was 23.5%, adjusted for tumour site, sex, age, ASA, urgency, laparoscopic entry and surgical procedure. There is a spectrum of Length of Stay (LOS) across hospitals, with a mean LOS of around eight days and median of seven days, this is comparable to the number of days reported in the United Kingdom (UK) 1. This has hardly changed over the past decade despite interventions initiated to reduce it. Variables that impact on LOS include age, ASA, urgency of admission, surgical complications, laparoscopic entry and surgical procedure. LOS increases as the tumours move from colon to rectum, with minor differences between right and left sided tumours. It increases with age and with urgency of hospital admission with a median LOS of nine days for an emergency admission, eight days for an urgent, and seven days for an elective operation. The adoption of a minimally invasive approach for resection has progressively increased over time, from under 3% in 27 to 66% in 217. Whilst laparoscopy is the predominant approach for colonic resection, there has been an increase in non-laparoscopic minimally invasive approaches for rectal resection, including robotic resection and transanal Total Mesorectal Excision (tatme). 6 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

The most common operation undertaken for colon cancer is right hemicolectomy and the proportion of colonic resections undertaken laparoscopically in 217 was almost 7%. The overall rate of surgical complications was 2%. With respect to tumour stage, 29% of cases are Stage III and 13% are Stage IV. The proportion of Stage IV cases is lower than that reported in the literature (2% at presentation). However, this may reflect that this database catches mainly those that have had surgery, and with improving chemotherapy more Stage IV cases may be going to chemotherapy initially, and not proceeding to resection. The number of lymph nodes removed may be considered a surrogate marker for the quality of the surgical resection. The mean number of lymph nodes removed was 17.5, and this has increased slightly over time since 27. Management of rectal cancer is frequently more complex than colon cancer and it is encouraging to note that the proportion of rectal cancer cases discussed at a Multidisciplinary Team meeting (MDT) has increased from 51% in 215 to 68% in 216 and now 71% in 217. The use of staging MRI has also increased dramatically from 25% in 27 to nearly 8% in 217. There have been a high proportion of cases staged with MRI since 29, which is likely to be secondary to changes in the Australian Pharmaceutical Benefits System (PBS) when MRI staging for rectal cancer was listed on the PBS. Just over half the patients with rectal cancer have received neoadjuvant therapy, the majority receiving long course chemoradiotherapy. End stoma rate can be a marker of quality of care in rectal cancer surgery. A proportion of patients will require an end stoma as it will not be possible to curatively resect their rectal tumour. The end stoma rate was 23% with either an abdominoperineal resection in 19% or a Hartmann s procedure in the remaining cases. There is a spectrum of frequency across units, with a reduction in frequency in units with greater numbers of cases reported. The proportion of rectal cancers resected with open resection is 34% in 217 which is small decrease from 216. There is a small increase in the proportion of laparoscopic resections. The number of hybrid procedures are the same as 216, and the number of alternative minimally invasive approaches such as tatme are small but with a slight increase. Alterations in practice seem to have stabilised after the potential concern that a laparoscopic approach may not be optimal in a proportion of rectal cancers following the publication of the North-American Z651 2 trial and the Australasian ALaCaRT rectal cancer trial 3. Circumferential resection margin (CRM) is an important marker of quality of surgery, as CRM involvement is strongly associated with an increase in local tumour recurrence. The rate of CRM involvement reported is respectable at 7% and has slowly reduced since 27, plateauing over the last 6 years. The overall rectal cancer surgical complication rate is 31.3%. There is a spectrum in complication rates across the different hospitals. The overall anastomotic leak rate of 3.4% would generally be considered commendably low 4. The utilisation of adjuvant therapy is high across Stage III patients of all ages, only reducing in patients aged over 8 years. The uptake is lower is Stage II disease as would be expected, however it is higher in patients under 5 years, reducing proportionately with increasing age. The research output utilising the data in the BCCA has increased, with a recent leading article 5 and editorial 6 published in Diseases of the Colon and Rectum, and several research projects are currently underway. THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 7

MESSAGE FROM STEERING COMMITTEE CHAIR The BCCA Steering Committee was formed in 215, this corresponded to the development of a new governance document which was based on the recommendations of the Operating Principles and Technical Standards for Australian Clinical Quality Registries. At this same time, the original Colorectal Cancer Audit Committee became the BCCA Operations Committee, which is responsible for managing the day-to-day aspects of the BCCA database. The Steering Committee is responsible for overseeing BCCA and, the running of the audit is managed by the Operations Committee. The Steering Committee meets twice a year, once by teleconference and the other meeting is usually a face-to-face workshop combined with the Operations Committee and this is usually held at the time of the May Royal Australasian College of Surgeons (RACS) Annual Scientific Congress. Previous meetings have been extremely useful in providing direction and developing policies. The Steering Committee is made up of eight members, which include the chair (Andrew Hunter), who is a member of CSSANZ and nominated by the Colorectal Surgical Society of Australia and New Zealand Council. In addition, there are representatives from CSSANZ Council (Jamie Keck), RACS section of colon and rectal surgery (Ian Faragher), General Surgeons Australia (Trevor Collinson), New Zealand Association of General Surgeons (Grant Coulter), as well as another clinician with an interest in colorectal cancer (John Zalcberg) and a consumer representative (John Stubbs) and finally the chair of the BCCA Operations Committee (Alexander Heriot). The Steering Committee is responsible for monitoring data output and ensuring quality of care issues are addressed appropriately. In addition, the Steering Committee ensures that an appropriate structured process has been developed for peer review and ensures that feedback to organisations occurs in an appropriate manner. Generally, at each meeting the chairman of the Operations Committee will give a report of the activities of the BCCA over the last few months. At the most recent workshop, topics for discussion included governance, strategic planning, funding, clinical quality policy as well as other important issues such as data importing, state and national cancer registries, Medical Research Future Fund, data participation, data quality and staffing issues. The Steering Committee has provided valuable advice and support to the Operations Committee and is well represented by experienced clinicians from several different interest groups with expertise and involvement in the management of colorectal cancer. Andrew Hunter Chair BCCA Steering Committee 8 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

WHAT IS BCCA The Bi-National Colorectal Cancer Audit (BCCA) is a surgical audit applicable to all surgeons who perform colorectal cancer surgery. It is a surgeon driven project led by a group of surgeons who are committed to excellence in the prevention, diagnosis and treatment of patients with colorectal cancer. The BCCA aims to create a large integrated dataset to be used for quality improvement and future research. Audit is a requirement of registration for surgeons in Australia and New Zealand and BCCA is a recognised audit for this purpose by the Royal Australasian College of Surgeons (RACS). BCCA data is recorded per surgeon per site, and information is collected about patient diagnosis, treatment and surgical outcomes. The database is secure and accessible via any Internet browser. Surgeons can run live deidentified summary reports at any time, comparing their outcomes to their site and to the whole database. Surgeons also have access to their own raw identifiable data at any time at the click of a button after logging into the secure system. BCCA is a Clinical Quality Registry (CQR), which aims to improve the safety or quality of health care provided to patients by collecting key clinical information from individual healthcare encounters which enable risk-adjusted outcomes to be used to drive quality improvement 8. CQRs can provide the most suitable and accurate method of providing monitoring and benchmark data and, where applicable, offer the greatest potential to improve health care performance across institutions and providers. By creating a large integrated dataset BCCA will be able to assist with setting benchmarks in colorectal surgery in Australia and New Zealand and thereafter the identification of outliers. All surgeons practicing in Australia and New Zealand are required to participate in peer-reviewed surgical audit as part of their registration 9 ; and by participating in a larger audit such as BCCA surgeons can compare their data to a larger pool of data thus making their audit more effective and meaningful. BCCA makes effective auditing accessible to all surgeons throughout Australia and New Zealand who have appropriate approvals in place and access to the Internet. THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 9

WHERE ARE WE NOW? Since the last report there have been some valuable developments for BCCA. Some of the highlights include: Reduced administrative burden associated with ethics approvals; in 217 all hospitals participating in the National Mutual Acceptance (NMA) model of ethics review were transitioned to a single ethics approval with Melbourne Health Human Research Ethics Committee (HREC). By reducing the number of HRECs associated with BCCA, we can significantly reduce the administrative burden faced by BCCA staff and participating surgeons. Revision of the BCCA Protocol; Version 3 of the BCCA Protocol was approved by the BCCA Operations Committee and is currently being implemented at all participating sites. This new protocol includes a waiver of consent for historical data to be included in the database, a revised consent procedure so that patients are exposed to a BCCA poster in their surgeon s waiting room and the ability to link with external datasets. Release of data for projects under the data access policy; in 217 three research projects were approved and data released for analyses. Specific details of these projects can be found on pages 13 and 14. Implementation of a data import feature; by mapping data to a BCCA data template (in Excel), surgeons and hospitals that run equivalent datasets are now able to participate in BCCA by uploading their data directly into the online system. This feature went live in September 217. Development of a new quality assurance framework; a key component of BCCA is its utility as a quality assurance tool, this includes using the data to set relevant benchmarks and use these benchmarks to identify outliers. A Clinical Quality Policy was ratified in 217 and Quality Reports providing personalised hospital-specific data was piloted. It is envisioned this pilot will be rolled out in the coming years. Strategies to continue increasing participation; in order to set effective benchmarks, it is important that the data submitted is representative of current practice, therefore increasing participation across Australia and New Zealand continues to be a priority. BCCA management committees continue to engage with other stakeholders to promote participation in BCCA. In 217 BCCA made significant strides towards this as a number of new surgeons and hospitals were added to the database. In particular a number of regional sites were added to the registry, a development which will likely lead to more representative data. 1 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

BCCA GOVERNANCE The BCCA governance model complies with the National Operating Principles for Clinical Quality Registries as set out by the Australian Commission on Safety and Quality in Health Care 7. The registry is overseen by the BCCA Steering Committee in coordination with the BCCA Operations Committee. Employment and financial management remains under the auspices of the CSSANZ Council. Day to day management of the database is achieved by a Project Manager who reports to the Operations Committee monthly. The Steering Committee is comprised of various stakeholders including clinicians, funders, consumers and other relevant specialists. The Steering Committee is responsible for oversight of BCCA activities, including that of the Operations Committee, providing ongoing review of objectives and effectiveness in meeting these and approving any new policies to address issues of clinical interest that may arise. The membership is as follows: Chair Mr Andrew Hunter One member of the CSSANZ Council Mr James Keck One member of the Royal Australasian College of Surgeons (RACS) Colon and Rectal Surgery Section Executive Mr Ian Faragher One representative recommended by the General Surgeons Australia (GSA) Council Mr Trevor Collinson The Operations Committee is responsible for the day to day management of BCCA, developing quality measures and forming relevant sub-committees to address data access, research and quality issues. The membership is as follows: Chair Professor Alexander Heriot (Victoria) Representatives of the Department of Epidemiology & Preventive Medicine, Monash University (DEPM) Professor Christopher Reid Ms Angela Brennan A representative of CRC Audit (the extended dataset) Associate Professor Paul McMurrick (Victoria) Surgeons who regularly undertake surgery for colorectal cancer providing a broad geographic binational representation; Associate Professor Chris Byrne (New South Wales) Professor Pierre Chapuis (New South Wales) Dr Mark Doudle (Queensland) Dr Elizabeth Murphy (South Australia) Professor Cameron Platell (Western Australia) Associate Professor Mark Thompson-Fawcett (New Zealand) Other co-opted members as required; currently none. Sub-committees will be formed under the Operations Committee to address data access, research and quality. One representative recommended by the New Zealand Association of General Surgeons (NZAGS) Mr Grant Coulter A clinician with an interest in colorectal cancer Professor John Zalcberg One consumer representative Mr John Stubbs Chair of the BCCA Operations Committee Professor Alexander Heriot THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 11

DATA ACCESS BCCA s primary functions are: Facilitate clinical audit/s to improve patient safety; Create a large dataset of surgical information whereby it will be possible to stratify the data and establish benchmarks; Monitor surgical performance by peer review; and Provide feedback to surgeons in the form of summary statistics and individual reports regarding their performance. These functions are managed by the BCCA Operations Committee, in particular a Clinical Quality Committee (CQC). This Committee will be responsible for establishing clinical audit systems, developing and maintaining a risk-stratification model utilising BCCA data to facilitate benchmarks, implementing peer review processes and providing feedback. Feedback to surgeons in the form of summary statistics and individual reports regarding their performance is in-built to the online BCCA system and surgeons can access this resource at any time. The primary functions which are projects seen as core business of BCCA (risk- stratification, benchmarking) will not be approved as research projects for units wishing to access BCCA data. BCCA s secondary functions include: Facilitate research and research projects; and Advance knowledge and understanding of the optimum treatment for colorectal cancer to help ensure best practice. DATA ACCESS FOR RESEARCH BCCA encourages the use of BCCA data for the purpose of research. If you are a clinician or researcher who contributes data to BCCA or affiliated with a group who contributes to BCCA, we encourage you to utilise the information in the dataset. The BCCA Steering and Operations committees support opportunities for research in the area of colorectal cancer surgery performance, procedures, treatment and outcomes. BCCA supports the International Committee of Medical Journal Editors (ICMJE) recommendations for authorship 1. Participation in BCCA is not an assurance of authorship on any research project or paper, rather authors should have: i. contributed substantially to the conception and design of the study, the acquisition of data, or the analysis and interpretation; ii. drafted or provided critical revision of the article; and iii. provided final approval of the version to publish. BCCA should be acknowledged in any presentation or publication resulting from included data extracted from BCCA data. BCCA promotes opportunities for research and aims to engage BCCA users to be active in the utilisation of BCCA data. Deidentified BCCA data is available to users and those affiliated to users for research purposes. Consultants who agree to make their deidentified data accessible to others for research will also be able to access other users deidentified data. Data is deidentified by patient, surgeon and site. Consultants who do not want their deidentified data included for others to access for research will not be able to access other consultants deidentified data for their own research. Applications will be reviewed on a case by case basis by the Research Committee and they will make recommendations to the BCCA Operations Committee for approval. They may request further information, seek evidence of appropriate ethical approvals, co-opt specialist members for advice or provide other feedback. Each researcher or unit may submit one research application for data access at a time (unless a special case can be made for a change to this policy). Once that project is complete, additional submissions may be made. It is expected that a research project will be completed within 6 months. Beyond this time, approval for projects will be withdrawn and data will be available to other units for the specified project. Evidence of completion and a summary report of research will be required for submission to the BCCA Committees for their review. A unit must not go outside the scope of their original proposal; if a unit conducts research outside the scope of the original approval that unit will be denied access to data for three years. Any abstracts or papers produced must be submitted to the Research Committee for approval prior to presentation or publication. 12 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

RESEARCH The BCCA Data Access Policy was released at the beginning of 216, this has allowed researchers to access and utilise useful clinical information to answer their own research questions. PUBLICATIONS: Warrier, S.K., Kong, J.C., Guerra, G.R., Chittleborough, T.J., Naik, A., Ramsay, R.G., Lynch, A.C. & Heriot, A.G. (218). Risk Factors Associated With Circumferential Resection Margin Positivity in Rectal Cancer: A Binational Registry Study. Diseases of the Colon & Rectum, 61(4):433-44. PRESENTATIONS: Rasmussen, M., Platell, C & Jones, M. (217, May). Funnel plots and statistical process control methods to monitor excess Unplanned Return to Theatre (URTT) following colorectal surgery. Poster presented at the Royal Australasian College of Surgeons Annual Scientific Congress 217, Adelaide, Australia. APPROVED RESEARCH PROJECTS: 1. What s the best technique for comparing hospital performance on return to theatre data? Funnel plots? Risk-adjustment? Multilevel regression analyses? Investigator: Professor Cameron Platell, St John of God Subiaco Status: Complete, submitted to journal for publication. Variability in 3-day return to theatre rates is an important quality indicator for monitoring surgical performance. The aim of this study was to provide the Bi-National Colorectal Cancer Audit (BCCA) with a predictive model of return to theatre that accommodates for very different hospital and patient risk profiles. 2. Validation of the ACPGBI risk prediction model for 3-day mortality after surgery for colorectal cancer does it apply in Australia? Investigator: Associate Prof Paul McMurrick, Cabrini Institute Status: In progress. The project will be used to derive a risk stratification formula from all data from participating BCCA sites. This will allow for a comparison of outcomes from various clinical centres, and to also make statistical allowance for the differences in the underlying risk of their patient population, allowing meaningful comparison of results, with a view to ensure the safety of patient care. THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 13

APPROVED RESEARCH PROJECTS CONTINUED 3. Factors affecting CRM positivity in rectal cancer resection and the impact on management. Investigator: Mr Satish Warrier, Peter MacCallum Cancer Centre Status: Complete, podium presentation at the 217 The American Society of Colon and Rectal Surgeons (ASCRS) Annual Scientific and Tripartite Meeting and published in Diseases of the Colon & Rectum April 218 as listed above. This project assesses the quality of rectal cancer resection across Australasia and identify factors that may influence Circumferential Resection Margin (CRM) positivity. In particular the difference in socioeconomic status; public versus private hospitals; rural versus urban hospitals; and the level of training received at the time of surgery (registrar-in-training, fellow-in-training or consultants). The paper was the lead paper in Diseases of the Colon & Rectum and was accompanied by the lead editorial stressing the value of data analysis of cancer registries. 5. Short Term Outcome of Emergency Colorectal Cancer Surgery: Results from Bi-National Colorectal Cancer Audit. Investigators: Mr Angus Lee, Dr Paul Sitzler, Mr Joseph Kong, Epworth Hospital, Melbourne Status: Complete, submitted to journal for publication. The study assesses the differences between colorectal cancer cases presenting as an emergency or urgent case versus an elective case. Tumours presenting as an emergency or urgent case are usually more advanced and have a higher complication rate after surgery. The patients are also more likely to receive a stoma. 6. Outcomes of surgical treatment of colorectal cancer in patients over 8 years of age. Investigators: Professor Frank Frizelle, A/Prof Tim Eglinton, Dr Andrew McCombie, Ms Jacqueline Lidin, University of Otago, Christchurch Status: In progress. 4. Predicting pathological complete response and associated survival outcome in rectal cancer project. Investigators: Mr Joseph Kong, Peter MacCallum Cancer Centre Status: Complete, in preparation for publication. The primary aim of this project is to identify the clinical and pathological variables that can influence the rate of pathological complete response after neoadjuvant chemoradiotherapy in locally advanced rectal cancer. The secondary outcome is to assess the influence of tumour regression grade in predicting survival outcomes. This project is part of the investigators PhD thesis and will be used as a starting point in identifying novel biomarkers to predict response to neoadjuvant chemoradiotherapy in patients diagnosed with locally advanced rectal cancer. The objectives of this project are to assess the presentation, management and outcomes of patients 8 years and over compared to those under 8 years after surgery for colorectal cancer. Subsequently, as part of a larger project, use this data to contribute to a decision tool for surgery for colorectal cancer in the over 8s. For further information about these projects please contact the investigators. 14 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

CLINICAL QUALITY In 217 the BCCA Clinical Quality Policy was ratified by both the BCCA Operations and Steering Committees. As mentioned above the BCCA Operations Committee and in particular the CQC is responsible for managing BCCA s primary functions and thus the implementation of this policy. The membership of the CQC will be made from members of the BCCA Operations Committee. Below is a summary of the ratified Clinical Quality Policy. Tasks of the CQC include: Develop and regularly review risk adjustment models utilising the data within the BCCA database to facilitate benchmarks. Develop and implement procedures for identifying and managing areas of clinical concern that may arise through the data collection process in BCCA. Develop and implement procedures for identifying areas for potential quality improvement. Report summary findings to the Operations Committee in a deidentified manner. Adopt processes for identifying and managing outliers. Develop and implement procedures of communication with participating sites/surgeons who may be identified as outliers. Provide Clinical Quality data to participating units with a focus on the identified Key Performance Indicators (KPIs). MONITORING QUALITY IN COLORECTAL CANCER SURGERY Key Performance Indicators (KPIs) The purpose of KPIs are to provide discrete quality end points which directly reflect both quality of care and patient safety. The BCCA KPIs are defined by a consensus discussion of the Operations Committee with approval from the BCCA Steering Committee and will be reviewed on a yearly basis. Primary KPIs are considered to be discrete quality end points which directly reflect quality of care with appropriate risk adjustment. The following primary KPIs were approved for review in the 217 policy. Primary KPIs: Inpatient death Return to theatre Anastomotic leak rate Number of lymph nodes examined (colon) Circumferential margins (rectal) Secondary KPIs are factors which may reflect quality of care, however can be influenced by individual clinical practice and therefore cannot be considered as discrete quality end points. The following secondary KPIs were approved for review in the 217 policy. Secondary KPIs: Adjuvant chemotherapy Length of stay Surgical complication rate (complications analysed include; Abdominal pelvic collection, Anastomotic leak, Enterocutaneous fistula, Superficial wound dehiscence, Deep wound dehiscence, Wound infection, Temperature > 38.5 C with haemodynamic features of sepsis, Prolonged ileus, Small bowel obstruction, Urinary retention, Ureteric injury, Splenectomy, Postoperative haemorrhage, Other) Discussed at MDT (rectal) MRI staging (rectal) Permanent stoma rate Reporting of KPIs Most KPIs are available to all surgeons and units at any time through self-review of their live Outcomes Report. Both individual surgeons and units can independently benchmark themselves against the whole BCCA binational dataset by utilising this report. To access this report a user just needs to log into the system and THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 15

select Report>Outcomes then tailor the report to their requirements (time frame, colon vs rectum and other filter features). Once a KPI system is implemented the reporting of KPIs will be produced by the BCCA Data Managers. Reports will be prepared per unit, including pooled data of all the surgeons at the site; individual surgeon reports will not be prepared. Reports will be produced annually, and the data will include both raw and where possible, risk adjusted data. A summary report of all sites will be reviewed by the CQC and/or Operations Committee before distribution. The report will be distributed to all surgeons submitting data from the site. To receive such a report, the unit must be submitting regular data within the previous year. Management of KPIs Reporting of KPIs will occur on an annual basis to monitor the quality of colorectal surgical care delivered to patients. This will allow for the BCCA committees to consider how treatment outcomes may be improved and to advocate for relevant policy developments. All reports will be generated on a site-based level. Funnel plots will be employed for identifying outliers. Threshold limits will be set at two and three standard deviations above or below the pooled mean. The pooled data will be all data that has been submitted to BCCA since 27, as BCCA grows and participation increases this will be reviewed with the possibility of moving to the pooled data comprising of a rolling group of three years or even annual data. It is anticipated that outliers will be defined as KPI results that are three standard deviations above or below the pooled mean for that variable, which ever direction is the appropriate for the specific KPI. Sites identified as exceeding the bounds of common cause variation will be notified and a cooperative review process will commence, with the view to resolving any discrepancies and/or identify factors contributing to the results of the report(s). The reports will include a data summary that shows a unit where they sit on the funnel plot in comparison to all other participating BCCA units. Their unit will be identified on each funnel plot allowing easy comparison to other sites. The other sites are deidentified in this report. Where statistically significant performance discrepancies are confirmed across consecutive reporting periods, BCCA will initiate a cooperative process with sites to facilitate the identification and clarification of data issues that may be contributing to the reported patient outcomes. In the instance where sites are consistently performing better than the pooled mean(s) BCCA will not investigate these results further. Additional data may also be required during the peer review and routine reporting processes. The CQC and/ or Operations Committee will review reports and any additional requirements from stakeholders as they arise. The CQC and Operations Committee will also endeavour to guide sites with data management. It is important to note that the BCCA dataset is only representative of those who participate in BCCA; outliers may be identified who may be within the common bounds if all colorectal cancer surgeries in Australia and New Zealand were entered into BCCA. Therefore, the data and certainly the initial reports must be interpreted with this in mind. Process for Review of Outliers Where discrepancies in performance are first identified, a review of data management activities for that site will be recommended to ensure that any identified outliers have not been identified in error. In the instance where a site is identified as performing outside the bounds of common-cause variation for more than one consecutive reporting period after the data has been verified to be accurate, the Head of unit or nominated representative responsible for audit at that site will be advised. The CQC (or nominated delegate) will then review the data in question to ensure that any outliers identified are statistically significant. This process will be strictly confidential between the CQC and participating unit. It should be emphasised that BCCA encourages an internal review and will collaborate with sites to facilitate identification of the source of the discrepancies. The site(s) will then be encouraged to share the results of their data review with BCCA. Where sites require guidance and support, BCCA may provide advice with this process. INTERPRETATION OF BCCA DATA During the formation period of BCCA it is important to acknowledge that the extrapolation of BCCA data may be very limited. Data will not be representative of practice of all colorectal cancer surgery outcomes in Australia and New Zealand until participation is representative across all relevant areas. 16 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

BCCA METHODOLOGY From 27 to December 213 BCCA data was collected via paper forms with the majority of these sent for entry at the RACS Research, Audit and Academic Surgery Division. Other sites have stored these forms locally on an equivalent database. In December 213, the online BCCA database was launched and as sites attain amendments to their ethical approvals to allow utilisation of this new model they have migrated to the online system. All sites must have appropriate approvals in place to participate. This varies from region to region, and it includes but is not limited to Ethics Committee approval, Research Governance approval, Public Health Act approval (QLD only) and specific hospital level approvals. See page 59 BCCA Participation for more information regarding the process per region. Patients are informed by their surgeons or treating team of the surgeon s participation in BCCA and are given the opportunity to opt-out of having their data included in the database. The online database was developed by and is maintained by Clinical Data Management Systems (CDMS) and the School of Public Health and Preventive Medicine (SPHPM) at Monash University. The database is accessible via any Internet browser. Surgeons, site-managers or support staff can enter data directly into the database after logging in via a secure encrypted page. The online system has in-built processes to ensure data completeness and data integrity. Data can be saved, and further details added later, data will only be accepted in approved formats ensuring there are no inconsistencies in reporting, and incomplete cases remain on the home page after login as a reminder to complete them. Surgeons and Sites can only see identifiable data that they have submitted but can run anonymised summary reports comparing themselves to the whole database getting live feedback regarding their performance. In 216 an automatic data feed was implemented linking the CRC Audit to BCCA, this allows participants of CRC Audit (the extended dataset) to automatically participate in BCCA (the minimum dataset). This automatic data feed reduces the amount of data handling required ensuring data integrity. The CRC Audit currently covers select sites within the Monash Partners network. In 217 an import tool went live that enables data to be imported to the BCCA registry via an Excel spreadsheet template. For sites that already contribute to a colorectal cancer database or collect comparable data for audit, this provides a method of transferring data from their system into the BCCA without having to enter the same data twice. Depending on the original data format some manipulation may be required for example a no may have to be changed to a zero to match the BCCA template, but this can easily be done within Excel. THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 17

DATA HANDLING In February 218, the data entered to the online BCCA system up until surgery date 31 December 217 was extracted for analyses. This data was combined with the data from the St John of God (SJOG) Colorectal Cancer Database. These two datasets are merged for the purposes of this report. In 218, it is anticipated that the SJOG Colorectal Cancer Database will be able to utilise the BCCA data import system. In February 218, the data entered to the online BCCA system up until surgery date 31 December 217 was extracted for analyses. This data was combined with the data from the St John of God (SJOG) Colorectal Cancer Database. These two datasets are merged for the purposes of this report. In 218, it is anticipated that the SJOG Colorectal Cancer Database will be able to utilise the BCCA data import system. Throughout the report analyses were undertaken where complete data was available, cases with missing information were excluded per question. Where deemed relevant, sections include details about how many Treatment Episodes (TE) were included in the analysis. Funnel Plots are used throughout the report; they are a visual representation of how many outliers there are; they identify those who are performing better or worse than the average. The funnel plot curves represent two standard deviations (95% control limits) and three standard deviations (99.8% control limits) from the mean, those above and below these lines are considered outliers. In the preparation of funnel plots all units of less than 1 patients were included in a single group (patients in all, labelled group ZZ), including this group, there were 79 units analysed. For the 79 units the median number of patients was 11, mean 236, with a range from 12 patients to a maximum of 1,596 patients. Length of hospital stay (LOS) data was capped at 3 days; this represents 97% of all data submitted. Higher stays were not included in the LOS analyses due to potential data entry errors with the range up to 1,111 LOS reported. This approach was also applied to the Lymph Node data, with the highest figure being capped at 4 as this represents 98% of all data submitted. Before this exclusion criterion was applied the maximum Lymph Nodes collected reported was 189. Box and whisker plots are presented throughout the report. The box borders identify the first quartile (a number for which 25% of the data is less than that number), the median, and third quartile (a number for which 75% of the data is less than that number). The mean is highlighted in the centre. The interquartile range (IQR) is the difference between the first and third quartile. The whiskers illustrate the lowest measurement still within 1.5 times the IQR of the first quartile, and the highest measurement still within 1.5 times the IQR of the third quartile (often called the Tukey boxplot ) 11. Most of the funnel plots present unadjusted crude rate or mean while others (where noted) are risk-adjusted. Riskadjustment considers differences in risk-factors; it enables adjustment for confounding variables. Risk-adjusted figures in the current report take different variables into account and these are noted under each graph. Some of the variables adjusted for include ASA grade, age, urgency of surgery, complications and position of tumour. Outliers are represented as coloured dots in the plots. The data from one outlier was removed as on investigation it was determined that the data had been incorrectly entered. 18 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

DATA COMPLETION There is a spectrum of data completeness over time and on review of 29 key data elements we observe that data completion has improved over time. We believe the online system (launched in February 21 for CRC Audit and in December 213 for BCCA) has facilitated improved data completeness as evidenced in Figure 1. Due to the nature of data being updated retrospectively we once again see a dip in data completion for the most recent period. FIGURE 1. PERCENTAGE DATA COMPLETION OVER TIME FOR 29 KEY BCCA ITEMS 92% 9% PERCENTAGE OF DATA ENTERED 88% 86% 84% 82% 8% 27 28 29 21 211 212 213 214 215 216 217 YEAR DATA SUBMISSION As seen in previous reports data submission has steadily increased since 27. Some surgeons and sites were still finalising their 217 data at the time of extraction so we anticipate the 217 numbers to increase further. FIGURE 2. TOTAL TREATMENT EPISODES SUBMITTED TO BCCA OVER TIME 25, 23,49 NUMBER OF TREATMENT EPISODES 2, 15, 1, 5, 2,846 17,824 14,754 11,881 9,912 7,867 5,566 3,484 598 1,914 27 28 29 21 211 212 213 214 215 216 217 YEAR THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 19

PARTICIPATING SITES TABLE 1. HOSPITALS PARTICIPATING IN BCCA State Hospital Collecting data Before 215 In 215 In 216 In 217 ACT Calvary ACT ACT Canberra Hospital NZ Auckland City Hospital NZ Christchurch Hospital NZ Dunedin Hospital NZ Grace Hospital NZ Hawkes Bay Regional Hospital NZ Mercy Ascot Hospital NZ Middlemore Hospital NZ North Shore Hospital NZ Ormiston Hospital NZ Royston Hospital NZ Southern Cross Christchurch NZ Southern Cross Invercargill NZ Southern Cross New Plymouth NZ Southern Cross North Harbour NZ Southland Hospital NZ St George s Hospital NZ Taranaki Base Hospital NZ Tauranga Hospital NZ Wanganui Hospital NZ Wellington Regional Hospital NSW Baringa Private Hospital NSW Belmont District Hospital NSW Calvary Riverina NSW Chris O Brien Lifehouse NSW Coffs Harbour Health Campus NSW Concord Repatriation General Hospital NSW Gosford Private Hospital NSW Gosford Public Hospital NSW Hurstville Private Hospital NSW John Hunter Hospital NSW Kareena Private Hospital NSW Lake Macquarie Private Hospital NSW Lingard Private Hospital NSW Maitland Hospital NSW Maitland Private Hospital NSW Mater Sydney NSW Nepean Hospital NSW Newcastle Private Hospital NSW North Shore Private Hospital 2 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

TABLE 1. HOSPITALS PARTICIPATING IN BCCA (CONTINUED) State Hospital Collecting data Before 215 In 215 In 216 In 217 NSW Norwest Private Hospital NSW POW Private Hospital NSW POW Public Hospital NSW Royal North Shore Hospital NSW Royal Prince Alfred Hospital NSW Ryde Hospital NSW St George Hospital NSW St George Private Hospital NSW St Vincent s Lismore NSW Sydney Adventist Hospital NSW The Tweed Hospital NSW Wagga Wagga Base Hospital NSW Westmead Public Hospital NSW Wollongong Hospital QLD Allamanda Private Hospital QLD Cairns Base Hospital QLD Cairns Private Hospital QLD Gold Coast University Hospital QLD Greenslopes Private Hospital QLD Holy Spirit Northside Private Hospital QLD Ipswich Hospital QLD John Flynn Private Hospital QLD Nambour General Hospital QLD Pindara Private Hospital QLD Princess Alexandra Hospital QLD QEII Jubilee Hospital QLD Royal Brisbane and Women s Hospital QLD St Andrew s Ipswich Private QLD St Andrew s War Memorial QLD Sunnybank Private Hospital QLD Sunshine Coast University Hospital QLD The Sunshine Coast Private Hospital QLD Townsville Hospital SA Ashford Hospital SA Calvary North Adelaide SA Calvary Wakefield SA Flinders Medical Centre SA Flinders Private Hospital SA Jamestown Hospital SA Lyell McEwin Hospital SA Modbury Hospital THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 21

TABLE 1. HOSPITALS PARTICIPATING IN BCCA (CONTINUED) State Hospital Collecting data Before 215 In 215 In 216 In 217 SA Naracoorte Hospital SA Port Lincoln Hospital SA Repatriation General Hospital SA Royal Adelaide Hospital SA St Andrew s Hospital SA The Queen Elizabeth Hospital SA Western Community Hospital TAS Calvary Lenah Valley TAS Hobart Private Hospital TAS Launceston General Hospital TAS Mersey Community Hospital TAS North West Regional Hospital TAS Royal Hobart Hospital TAS St Vincent s Hospital Tasmania VIC Alfred Hospital VIC Austin Hospital VIC Ballarat Base Hospital VIC Box Hill Hospital VIC Cabrini Hospital VIC Dandenong Hospital VIC Epworth Eastern Hospital VIC Epworth Geelong Hospital VIC Epworth Richmond Hospital VIC Frankston Hospital VIC Peter MacCallum Cancer Centre VIC St John of God Ballarat Hospital VIC St John of God Geelong Hospital VIC St Vincent s Hospital Melbourne VIC The Avenue Hospital VIC The Royal Melbourne Hospital VIC The Northern Hospital VIC Warringal Private Hospital VIC Western Hospitals WA Hollywood Private Hospital WA Osborne Park WA St John of God Murdoch WA St John of God Subiaco 22 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

LIST OF FIGURES Figure Title Page No. Figure 1. Percentage Data Completion over Time for 29 Key BCCA Items 19 Figure 2. Total Treatment Episodes Submitted to BCCA over Time 19 Figure 3. Age Distribution of Patients 26 Figure 4. Diagram of Primary Tumour Site, Count and Percentage 26 Figure 5. Age Distribution of Patients Diagnosed Following FOBT 29 Figure 6. Site of Tumour of Patients Diagnosed via a National Screening Program Compared to Other BCCA data 29 Figure 7. Stage of Cancer of Patients Diagnosed via a National Screening Program Compared to Other BCCA data 3 Figure 8. Hospital Mortality over Time 33 Figure 9. Post-surgical Inpatient Mortality by Hospital (unadjusted) 34 Figure 1. Risk-adjusted Post-surgical Inpatient Mortality by Hospital 34 Figure 11. Urgency of Admission and Inpatient Mortality Rate over Time 35 Figure 12. Return to Theatre Rate by Hospital (unadjusted) 36 Figure 13. Risk- adjusted Return to Theatre Rate by Hospital 36 Figure 14. Risk-adjusted Surgical Complications for all BCCA Treatment Episodes 37 Figure 15. Length of Hospital Stay by Hospital (unadjusted) 38 Figure 16. Risk-adjusted Length of Hospital Stay by Hospital 39 Figure 17. Length of Stay and Tumour Site 39 Figure 18. Length of Stay and Tumour Position 4 Figure 19. Length of Stay and Age 41 Figure 2. Length of Stay over Time 42 Figure 21. Length of Stay and Urgency of Admission 42 Figure 22. Summarised Operative Approach over Time 43 Figure 23. Detailed Operative Approach over Time 43 Figure 24. Detailed Operative Approach and Tumour Position 44 Figure 25. Summarised Operative Approach and Length of Stay 44 Figure 26. Operative Approach over Time for Colon Cancer 46 Figure 27. Relative Frequency of Surgical Complications for Colon Cancer 46 Figure 28. Tumour Stage for Colon Cancer 48 Figure 29. Mean Number of Lymph nodes (LN) Examined in Resected Specimen by Hospital 48 Figure 3. Lymph Nodes Examined in Resected Specimen for Colon Cancers over Time 49 Figure 31. Proportion of Patients with Rectal Cancer Undergoing MRI Scan as Part of Preoperative Staging over Time 51 Figure 32. Neoadjuvant Therapy Use for Rectal Cancer and Type of Therapy 51 Figure 33. Detailed Operative Approach over Time for Rectal Cancer 52 Figure 34. Permanent End Stoma Rate by Hospital for Rectal Cancer Patients 53 Figure 35. Circumferential Margin Involvement over Time in Rectal Cancer 54 Figure 36. Patients with Positive Margins and Neoadjuvant Therapy over Time 55 Figure 37. Surgical Complications in Rectal Cancer by Hospital 56 Figure 38. Percentage of Stage II and Stage III Patients who Received Chemotherapy 57 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 23

LIST OF TABLES Figure Title Page No. Table 1. Hospitals Participating in BCCA 2 Table 2. Patient Characteristics 25 Table 3. American Society of Anaesthesiologists (ASA) Classification for All Treatment Episodes 25 Table 4. Cancer Stage for All Treatment Episodes 27 Table 5. Number of Patients with Tumour Diagnosed Following FOBT over Time 28 Table 6. Primary Surgical Procedure for All BCCA Treatment Episodes 31 Table 7. Hospital Mortality over Time 32 Table 8. Urgency of Admission over Time 33 Table 9. Urgency of Admission and Inpatient Mortality 35 Table 1. Length of Stay and Tumour Position 4 Table 11. Length of Stay and Age 4 Table 12. Length of Stay over Time 41 Table 13. Length of Stay and Urgency of Admission 42 Table 14. Summarised Operative Approach and Length of Stay 44 Table 15. Primary Procedure for Patients with Colon Cancer 45 Table 16. Surgical and Medical Complications for Patients Undergoing Colon Cancer Surgery 47 Table 17. Tumour Stage for Colon Cancer 48 Table 18. Proportion of Rectal Cancer Cases Discussed at MDT 5 Table 19. Use of Neoadjuvant Therapy for Rectal Cancer 51 Table 2. Primary Procedure for Patients with Rectal Cancer 52 Table 21. Circumferential Margin Involvement over Time 53 Table 22. Use of Neoadjuvant Therapy and Margin Involvement 54 Table 23. Surgical and Medical Complications of Patients Undergoing Surgery for Rectal Cancer 55 Table 24. Percentage of Stage II and III Cancer Patients Receiving Chemotherapy 57 24 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

PATIENT CHARACTERISTICS Information on over 23,1 patients with colorectal cancer across Australia and New Zealand has been collected over the period from 27 to 217, with over 2,6 patients entered in 217. Despite the growth in the number of hospitals contributing data to the registry across Australia and New Zealand in 217, the 2,6 cases entered represents approximately 13% of the new colorectal cancer patients that would have presented over this period across both countries. It is likely that the aggregate BCCA cohort is representative of the general colorectal cancer patient population overall, including in terms of demographics. As in previous years the vast majority (92%) of patients are aged over 5 years at presentation, with patients aged between 7-79 years being the most common age group (3%) and those aged 6-69, the next largest group (26%), see Figure 3. The under 5 years age group made up 8% of new presentations across the 11-year period (n=1,877). This underscores the importance of ensuring that the message that colorectal cancer is not confined to the elderly is publicised. The age range, median and proportion of male to female patients in the cohort are shown in Table 2. The American Society of Anaesthesiologists (ASA) classification allows for an assessment of fitness for surgery of patients and provides an overall indication of the health of patients at the time of surgery. Almost 37% of patients are ASA 3 or greater (Table 3). This signifies that these patients have significant existing comorbidities, thus increasing the potential for postoperative complications. Approximately one third of tumours (3.5%) are in the rectum, with the majority of tumours situated in the sigmoid colon or beyond, similar to the previous report and consistent with the distribution reported in the literature (See Figure 4). The proportion of patients presenting with metastatic disease is 12%, lower than reported in other datasets 1 and therefore may not reflect the actual proportion of metastatic disease across Australia and New Zealand. Cancer stage according to the American Joint Committee on Cancer (AJCC) is shown in Table 4. Stage II and III cancers represent 6% of the cohort and compared with the previous report, Stage 4 cancer has dropped by 1% point overall. TABLE 2. PATIENT CHARACTERISTICS Age Range 18-11 Age Mean (±SD) 69 (±13) Age Median 7 Female: Male 1:1.2 TABLE 3. AMERICAN SOCIETY OF ANAESTHESIOLOGISTS (ASA) CLASSIFICATION FOR ALL TREATMENT EPISODES Percent ASA 1 3,338 14.81% ASA 2 1,96 48.4% ASA 3 7,43 32.86% ASA 4 864 3.83% ASA 5 21.9% TOTAL 22,632 1% ASA is a system for assessing the fitness of patients before surgery where 1 represents a healthy person and 5 represents someone who is not expected to survive without surgery. THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 25

FIGURE 3. AGE DISTRIBUTION OF PATIENTS 7, 6,5 6, 5,5 NUMBER OF PATIENTS 5, 4,5 4, 3,5 3, 2,5 2, 1,5 1, 5 <2 2-29 3-39 4-49 5-59 6-69 7-79 8-89 9+ AGE GROUP FIGURE 4. DIAGRAM OF PRIMARY TUMOUR SITE, COUNT AND PERCENTAGE* Transverse Colon 1,888, 8.4% Splenic Flexure 678, 3% Hepatic Flexture 1,1, 4.9% Ascending Colon 2,8, 12.5% Descending Colon 671, 3% Rectosigmoid 1,345, 6% Caecum 2,754, 12.3% Sigmoid Colon 4,236, 18.9% Rectum Upper Third 974, 4.4% Unknown 11,.5% Rectum Middle Third 2,523, 11.3% Rectum Lower Third 3,323, 14.8% *n=22,42 treatment episodes 26 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

TABLE 4. CANCER STAGE FOR ALL TREATMENT EPISODES Count (%) Stage* Colon Rectum TOTAL Stage 576 (4%) 432 (8%) 1,8 (5%) Stage I 2,676 (2%) 1,722 (31%) 4,398 (24%) Stage II 4,46 (34%) 1,229 (22%) 5,689 (31%) Stage III 3,833 (29%) 1,5 (27%) 5,333 (29%) Stage IV 1,575 (12%) 524 (1%) 2,99 (11%) Stage X 4 (<1%) 79 (1%) 119 (1%) TOTAL 13,16 (71%) 5,486 (29%) 18,646 (1%) * The AJCC staging system is a classification system developed by the American Joint Committee on Cancer for describing the extent of disease progression in cancer patients. It utilises the TNM scoring system to calculate an overall stage value, where T is Tumour size, N is Lymph Nodes affected, and M is Metastases. THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 27

FOBT DIAGNOSIS AND BOWEL SCREENING PROGRAMMES Whilst the majority of colorectal cancers present due to symptoms, a proportion are identified as a result of screening programs. The National Bowel Cancer Screening Program (NBCSP) was initiated in Australia in 27 following a successful pilot program. It utilises an immunological faecal occult blood test (FOBT) to identify occult lower gastrointestinal bleeding and patients with positive tests are offered a colonoscopy via their general practitioner. In 218, men and women turning 5, 54, 58, 6, 62, 64, 66, 68, 7, 72 and 74 will be invited to participate. This is scheduled to increase in 219 to offer screening every 2 years from age 5 to 74. Participation rates in Australia remain low but raising awareness with advertising is likely to improve this. In New Zealand, a pilot screening program was undertaken in the Waitemata District Health Board (WDHB) area, which started in October 211 and continued through to December 217. It has covered men and women aged 5 to 74 from the WDHB. In January 218 the WDHB transitioned to the new National Bowel Screening Programme (NBSP), this screening programme has been rolled out within the Hutt Valley and Wairarapa District Health Boards, with other District Health Boards to follow in a staged rollout in eligible people aged 6 to 74. A subset of patients from these District Health Boards are submitted to the BCCA and hence the data presented below includes patients from bowel cancer screening programmes in both Australia and New Zealand. The proportion of patients diagnosed following FOBT remains fairly steady however this has increased to 14% in 216 and 217. It will be interesting to see if this proportion progressively increases over the next few years as a result of the staged expansion of the program. The age distribution of patients identified is consistent with the age distribution of the screening program as would be expected. The distribution of tumour site is similar to the overall distribution of patients which is not surprising as screening is aimed at identifying asymptomatic patients and hence the distribution is likely to be identical to the overall colorectal cancer population. It is encouraging however that there does appear to be a stage shift in patients diagnosed through the NBCSP with a higher proportion of Stage I patients. This should increase the likelihood of curative treatment in these patients. TABLE 5. NUMBER OF PATIENTS WITH TUMOUR DIAGNOSED FOLLOWING FOBT OVER TIME 27 28 29 21 211 212 213 214 215 216 217 TOTAL Diagnosed following FOBT 11% 13% 11% 1% 1% 9% 11% 12% 11% 14% 14% 11% Not diagnosed following FOBT 89% 87% 89% 9% 9% 91% 89% 88% 89% 86% 86% 89% COUNT 658 1,12 1,47 1,829 1,914 1,797 1,797 2,68 2,866 2,825 2,511 21,332 28 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

FIGURE 5. AGE DISTRIBUTION OF PATIENTS DIAGNOSED FOLLOWING FOBT* 9 8 7 NUMBER OF PATIENTS 6 5 4 3 2 1 <3 3-39 4-49 5-59 6-69 7-79 8-89 9+ AGE GROUP *n=2,318 patients FIGURE 6. SITE OF TUMOUR OF PATIENTS DIAGNOSED VIA A NATIONAL SCREENING PROGRAM COMPARED TO OTHER BCCA DATA* 3 25 % Non-Screening Program % Screening Program 26.2 PERCENTAGE OF PATIENTS 2 15 1 5 12.5 9.2 12.6 1.3 5. 3.3 8.4 8.1 3. 2.8 3. 4.1 18.8 6. 7.7 4.3 6. 11.3 11.9 15.1 1.5 Caecum Ascending colon Hepatic flexure Transverse colon Splenic felxure Descending colon Sigmoid colon Rectosigmoid Rectum upper third Rectum mid third Rectum lower third *n=981 screening patients and 21,545 other BCCA patients THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 29

FIGURE 7. STAGE OF CANCER OF PATIENTS DIAGNOSED VIA A NATIONAL SCREENING PROGRAM COMPARED TO OTHER BCCA DATA* 5 45 4 43.7 % Non-Screening Program % Screening Program 35 PERCENTAGE OF PATIENTS 3 25 2 15 22.5 31. 19.7 28.7 24.9 1 5 11.7 7.6 5.4 3.4.7.8 Stage Stage I Stage II Stage III Stage IV Stage X CANCER STAGE *n=865 screening patients and 17,934 other BCCA patients 3 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

SURGICAL CARE Surgery is the primary treatment for most patients with colorectal cancer. The range of operations required is a result of the variable site of origin of the tumour. The data is categorised into: overall colorectal cancer care, length of hospital stay, operative approach, and specifics related to colon cancer and to rectal cancer respectively. Subcategories are addressed separately and presented below. TABLE 6. PRIMARY SURGICAL PROCEDURE FOR ALL BCCA TREATMENT EPISODES Operation Count Percentage Right hemicolectomy 7,189 29% Extended right hemicolectomy 1,141 5% Left hemicolectomy 854 3% Sigmoid colectomy 237 1% Total colectomy 362 1% Subtotal colectomy 77 3% Proctocolectomy 21 1% High anterior resection (1.1-15) 4,141 17% Low anterior resection (6.1-1) 2,114 9% Ultra low anterior resection (-6) 3,11 13% APR 1,377 6% Hartmanns 83 3% Miscellaneous operation (eg. for complication) 42 <1% Colo-anal anastomosis 7 <1% Transverse colectomy 213 1% Local excision 344 1% TEMS/TAMIS 292 1% Laparotomy only 137 1% Other 447 2% Non-operative (No Surgery) 967 4% TOTAL 24,757 1% THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 31

OVERALL COLORECTAL CANCER CARE Overall hospital mortality for patients with colorectal cancer remains steady over time at under 2%. It is recognised that urgency of hospital admission, namely elective, urgent, or emergency is a strong factor influencing hospital mortality and this is supported by the data presented below. Most (87%) of colorectal cancer cases are elective, 7% present as urgent cases, and 6% present as emergencies. Mortality for emergency cases (5%) remains substantially greater than that of urgent cases (3%), which is in turn less than that for elective cases (1%). Assessing quality of care is challenging as it is multifactorial and there are a range of outcomes that can be considered. Hospital mortality is an important outcome and is encouragingly low at 1.5% overall. If the mortality is assessed across all the hospitals, there is a reduction in mortality with increase in number of cases undertaken. The mortality data can be risk-adjusted for factors that influence mortality and factors that influence in-hospital mortality including age, ASA, urgency of admission, complications, location of tumour in the rectum, laparoscopic entry and surgical procedure. The risk-adjusted mortality is represented on a funnel plot and is consistent with the unadjusted data, demonstrating no outliers and hence no hospitals with significantly increased mortality. It is important to risk-adjust data as there is likely to be a variation in the spectrum of cases treated in different centres. Return to theatre may also be utilised as a quality marker of hospital care. There is a spectrum of rates across the hospitals, with a mean of 6.4%. The data can be riskadjusted for age, ASA, urgency, complications, location of tumour rectum, laparoscopic entry and surgical procedure, raising the mean return to theatre rate to 5.9%. There are no hospitals with a significantly increased return to theatre rate. Overall complications are presented for all operative cases. Subgroup analysis for colonic and for rectal cases are presented later. A range of factors affect overall complication rate including tumour site, sex, age, ASA, urgency, laparoscopic entry and surgical procedure. The mean adjusted complication rate is 23.5%. TABLE 7. HOSPITAL MORTALITY OVER TIME 27 28 29 21 211 212 213 214 215 216 217 TOTAL Treatment Episodes 549 1,81 1,369 1,832 2,47 1,657 1,65 2,479 2,697 2,714 2,356 2,431 Inpatients Deaths 12 2 24 24 42 29 19 36 44 34 4 324 Inpatient Mortality Rate 2% 2% 2% 1% 2% 2% 1% 1% 2% 1% 2% 2% 32 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

FIGURE 8. HOSPITAL MORTALITY OVER TIME 2,8 2,6 NUMBER OF TREATMENT PATIENTS 2,4 2,2 2, 1,8 1,6 1,4 1,2 1, 8 6 4 2 27 Treatment Episodes Inpatient Deaths 28 29 21 211 212 213 214 215 216 217 YEAR TABLE 8. URGENCY OF ADMISSION OVER TIME Admission 27 28 29 21 211 212 213 214 215 216 217 TOTAL Emergency Urgent Elective Count 37 73 8 1 127 1 111 166 22 181 144 1,321 % 6 6 5 5 6 5 6 6 7 6 6 6 Count 35 7 17 137 158 123 124 243 237 224 217 1,675 % 6 5 7 7 7 6 6 9 8 8 9 7 Count 52 1,168 1,371 1,827 1,992 1,85 1,718 2,415 2,62 2,57 2,58 2,46 % 88 89 88 89 87 89 88 86 86 86 85 87 Urgency of admission definitions: Emergency: patients requiring surgery within four hours of presentation, Urgent: patients requiring surgery within 24 hours of presentation, Elective: patients requiring surgery at a planned time. THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 33

FIGURE 9. POST-SURGICAL INPATIENT MORTALITY BY HOSPITAL (UNADJUSTED) 4 Postoperative Inpatient Mortality (mean 1.5%) RELATIVE FREQUENCY OF INPATIENT MORTALITY 3 2 1 AA DEW CP DA AL BF L 5 1, 1,5 2, NUMBER OF SURGERIES Dotted curves represent two standard deviations (95% control limits) and three standard deviations (99.8% control limits). FIGURE 1. RISK-ADJUSTED* POST-SURGICAL INPATIENT MORTALITY BY HOSPITAL 4 Adjusted Postoperative Inpatient Mortality (mean 1.5%) RELATIVE FREQUENCY OF INPATIENT MORTALITY 3 2 1 DE BZ CW AA BX WZZ CB DH BU DI AW L 5 1, 1,5 2, NUMBER OF SURGERIES Adjusted for Age, ASA, Urgency, Complications, Return to Theatre, Laparoscopic Entry, Surgery Type 34 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

TABLE 9. URGENCY OF ADMISSION AND INPATIENT MORTALITY 27 28 29 21 211 212 213 214 215 216 217 TOTAL Mortalities 2 4 7 5 1 6 4 6 1 6 8 68 Emergency Urgent Elective TOTAL Count 37 73 8 1 127 98 17 164 199 174 132 1,291 % 5% 5% 9% 5% 8% 6% 4% 4% 5% 3% 6% 5% Mortalities 1 1 2 3 6 6 2 3 11 7 5 47 Count 34 63 13 134 153 118 123 237 234 222 28 1,629 % 3% 2% 2% 2% 4% 5% 2% 1% 5% 3% 2% 3% Mortalities 9 15 15 16 26 16 13 27 23 21 27 28 Count 472 94 1,177 1,583 1,745 1,424 1,47 2,58 2,251 2,38 1,99 17,274 % 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% Mortalities 12 2 24 24 32 28 19 36 44 34 4 323 Count 543 1,76 1,36 1,817 2,25 1,64 1,637 2,459 2,684 2,74 2,249 2,194 % 2% 2% 2% 1% 2% 2% 1% 1% 2% 1% 2% 2% FIGURE 11. URGENCY OF ADMISSION AND INPATIENT MORTALITY RATE OVER TIME* 14% %PERCENTAGE OF PATIENTS WHO DIED 12% 1% 8% 6% 4% Emergency Urgent Elective 2% % 27 28 29 21 211 212 213 214 215 216 217 YEAR * Emergency n= 1,291, Urgent n= 1,629, Elective n= 17,274, Total n=2,194 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 35

FIGURE 12. RETURN TO THEATRE RATE BY HOSPITAL (UNADJUSTED) RELATIVE FREQUENCY OF PATIENT RETURNING TO THEATRE WITHIN 3 DAYS 6 4 2 AC K AG BH CE CG BQ F CL CS AL CT BP CR Return to Theatre within 3 days (mean 6.4%) BC AS 5 1, 1,5 2, NUMBER OF SURGERIES FIGURE 13. RISK- ADJUSTED* RETURN TO THEATRE RATE BY HOSPITAL 8 % PATIENTS RETURNING TO THEATRE WITHIN 3 DAYS 6 4 2 BM CM CZCU BL CE BD Risk Adjusted Return to Theatre Rates (mean 5.9%) BS L AQ BB BF BC 5 1, 1,5 2, NUMBER OF SURGERIES *Adjusted for Age, ASA, Urgency, Complications, Location of Tumour Rectum, Laparoscopic Entry, Surgery Type 36 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

FIGURE 14. RISK-ADJUSTED* SURGICAL COMPLICATIONS FOR ALL BCCA TREATMENT EPISODES 1 Adjusted Surgical Complications (mean adjusted 23.5%) 8 RATE OF SURGICAL COMPLICATIONS (%) 6 4 2 AC AY BQDICL BK BW BH CK AQ BB G CF BN BT BS AZ BX CD P M CJ CU BV BP BY BM CXDG NCO CR AW BF L 5 1, 1,5 2, NUMBER OF SURGERIES *Adjusted for Age, Sex, ASA, Surgery Type, Laparoscopic Entry, Urgency THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 37

LENGTH OF HOSPITAL STAY Length of stay (LOS) is an important outcome of surgical care. Whilst it inevitably has a direct economic impact on the overall cost of care and on the surgical throughput of individual hospitals, it may also reflect the quality of care of the patient journey. Complications will increase the length of stay. The economic challenges facing delivery of healthcare has resulted in LOS being an important surrogate marker for the efficiency of delivery of surgical care. The application of Enhanced Recovery after Surgery (ERAS) programs, including early feeding, early mobilisation, and specialist analgesic approaches have consistently demonstrated reductions in LOS in the literature. This has been combined with the increased use of minimally invasive surgical approaches such as laparoscopic surgery, with reduction in abdominal incisions facilitating early mobilisation and potential discharge of the patient. It is interesting to note however that LOS has been static since 27, stubbornly remaining with a mean LOS of around eight days and median of seven days, comparable to the number of days reported in the UK 1. There is a spectrum of LOS between the different hospitals. Variables that impact on LOS include age, ASA, urgency of admission, surgical complications, laparoscopic entry and surgical procedure. LOS increases as the tumours move from colon to rectum, with minor differences between right and left sided tumours. It increases with age which is expected but may be important when resourcing for the future with the increasing age of the population that are likely to require surgery. Urgency of admission remains an important factor with LOS, with a median LOS of nine days for an emergency admission, eight days for an urgent, and seven days for an elective operation. FIGURE 15. LENGTH OF HOSPITAL STAY BY HOSPITAL (UNADJUSTED) 2 Mean Postoperative Stay (mean 8.5 days) 15 MEAN LENGTH OF STAY (DAYS) 1 5 K BH AY CG BQ BT CS AQ DH BU AF BV BZ I DK BL BX CH CN CO W CU AJ BE AP BB AZ CF AL BN M CT AW BF BC L 5 1, 1,5 2, NUMBER OF SURGERIES 38 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

FIGURE 16. RISK-ADJUSTED* LENGTH OF HOSPITAL STAY BY HOSPITAL 2 Adjusted Mean Postoperative Stay (mean 8.4 days) 15 MEAN LENGTH OF STAY (DAYS) 1 5 AL DOBHCLCS BR BX BU BE CH CO CZDG P AJ N BG BB BN CF BPM AZ BS BF BC L 5 1, 1,5 2, NUMBER OF SURGERIES *Adjusted for Age, ASA, Urgency, Surgical Complications, Laparoscopic Entry, Surgery Type FIGURE 17. LENGTH OF STAY AND TUMOUR SITE 25 2 LENGTH OF HOSPITAL STAY (DAYS) 15 1 5 Caecum Ascending colon Hepatic flexure Transverse colon Splenic felxure Descending colon Sigmoid colon Rectosigmoid Rectum upper third Rectum mid third Rectum lower third TUMOR SITE THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 39

TABLE 1. LENGTH OF STAY AND TUMOUR POSITION Right Left Rectal FIGURE 18. LENGTH OF STAY AND TUMOUR POSITION 25 Count 5,878 7,112 5,333 Mean (+/- SD) 8 (+/- 5) 8 (+/- 5) 1(+/-5) Median 7 7 8 IQR 5 4 6 LENGTH OF HOSPITAL STAY (DAYS) 2 15 1 5 Right Left Rectum TUMOR POSITION TABLE 11. LENGTH OF STAY AND AGE <3 3-39 4-49 5-59 6-69 7-79 8-89 9+ Count 126 397 1,62 2,722 5,58 5,982 3,962 419 Mean (+/- SD) 8(+/-5) 8(+/-5) 8(+/-5) 8(+/-5) 8(+/-5) 9(+/-5) 9(+/-5) 1(+/-5) Median 6 7 7 7 7 7 8 9 IQR 4 5 4 4 5 6 6 7 4 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

FIGURE 19. LENGTH OF STAY AND AGE 25 2 LENGTH OF HOSPITAL STAY (DAYS) 15 1 5 <3 3-39 4-49 5-59 6-69 7-79 8-89 >9 AGE GROUP TABLE 12. LENGTH OF STAY OVER TIME 27 28 29 21 211 212 213 214 215 216 217 TOTAL Count 487 997 1,297 1,734 1,922 1,637 1,619 2,48 2,657 2,617 2,261 19,636 Mean (+/- SD) 9(+/-5) 8(+/-5) 8(+/-5) 9(+/-5) 9(+/-5) 9(+/-5) 8(+/-5) 8(+/-5) 8(+/- 5) 8(+/-5) 8(+/-5) 8(+/-5) Median 8 7 7 7 7 7 7 7 7 7 7 7 IQR 4 5 5 4 6 6 5 5 5 5 5 5 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 41

FIGURE 2. LENGTH OF STAY OVER TIME 25 2 LENGTH OF HOSPITAL STAY (DAYS) 15 1 5 27 28 29 21 211 212 213 214 215 216 217 YEAR TABLE 13. LENGTH OF STAY AND URGENCY OF ADMISSION Emergency Urgent Elective FIGURE 21. LENGTH OF STAY AND URGENCY OF ADMISSION 25 Count 1,197 1,535 16,87 2 Mean (+/- SD) 11 (+/-6) 1 (+/-5) 8 (+/-5) Median 9 8 7 IQR 6 6 5 LENGTH OF HOSPITAL STAY (DAYS) 15 1 5 Emergency Urgent Elective URGENCY OF ADMISSION 42 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

OPERATIVE APPROACH The adoption of a minimally invasive approach as compared to an open approach has progressively increased over time. In 27 fewer than 3% of colorectal resections were undertaken with a minimally invasive approach, increasing to 66% in 217. The type of minimally invasive approach has also changed over time, with increasing penetration of robotic resection and transanal Total Mesorectal Excision (tatme) into rectal resection. The application of a minimally invasive approach is more common in colonic cases than in rectal, with 58% of colonic cases and 51% of rectal cases undertaken minimally invasively. The increase in minimally invasive rectal approaches appears to be secondary to alternative approaches such as robotic and tatme rather than increased laparoscopic operations. Application of a minimally invasive approach significantly reduced the hospital length of stay. FIGURE 22. SUMMARISED OPERATIVE APPROACH OVER TIME 1 9 8 7 PERCENTAGE OF OPERATIONS 6 5 4 3 2 1 27 28 29 21 211 212 213 214 215 216 217 YEAR Open Minimally Invasive FIGURE 23. DETAILED OPERATIVE APPROACH OVER TIME 1 9 8 PERCENTAGE OF OPERATIONS 7 6 5 4 3 2 1 27 28 29 21 211 212 213 214 215 216 217 YEAR Open Laparoscopic Hybrid Conversion of Laparoscopic Robotic Transanal TaTME THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 43

FIGURE 24. DETAILED OPERATIVE APPROACH AND TUMOUR POSITION FIGURE 25. SUMMARISED OPERATIVE APPROACH AND LENGTH OF STAY 25 1 9 8 7 6 LENGTH OF HOSPITAL STAY (DAYS) 2 15 1 5 PERCENTAGE OF OPERATIONS 5 4 Open OPERATIVE APPROACH Minimally Invasive 3 2 1 Colon Rectum TUMOR POSITION Open Laparoscopic Hybrid Conversion of Laparoscopic Robotic Transanal TaTME TABLE 14. SUMMARISED OPERATIVE APPROACH AND LENGTH OF STAY Open Minimally Invasive Count 8,432 1,89 Mean (+/- SD) 1 (+/-6) 7 (+/-5) Median 8 6 IQR 6 4 44 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

COLON CANCER The most common operation undertaken for colon cancer is right hemicolectomy. The progressive increase in the proportion of operations undertaken laparoscopically continues. In 217, nearly 7% of operations were undertaken laparoscopically. The overall rate of surgical complications was 2%, with a couple of units having a slightly higher complication rate. Sixteen percent of patients had a medical complication related to surgery as outlined in Table 16. The data however is not currently risk stratified so it is not possible to make definitive comparisons of units at present, and the overall data only represents a proportion of the total colonic cancers resected. With respect to tumour stage, 29% of cases are Stage III and 13% are Stage IV. The proportion of Stage IV cases is lower than that reported in the literature (2% at presentation). However, this may reflect that this database catches mainly those that have had surgery, and with improving chemotherapy more Stage IV cases may be going to chemotherapy initially, and potentially as the only palliative treatment. A trend to less resection in Stage IV has been reported by others 12. The number of lymph nodes removed is a surrogate marker for the quality of surgical specimen, demonstrating adequacy and quality of resection, and the quality of the pathology service. The thinking is that a good lymph node harvest will improve the accuracy of the staging and allow best application of adjuvant therapy. The mean number of lymph nodes removed was 17.5, and this has increased slightly over time since 27. Guidelines vary as to the minimal expected number of lymph nodes removed but 12 is often considered a minimal expected number 13. TABLE 15. PRIMARY PROCEDURE FOR PATIENTS WITH COLON CANCER Operation Count % Right hemicolectomy 6,74 47% Extended right hemicolectomy 1,28 8% Left hemicolectomy 773 5% Sigmoid colectomy 172 1% Total colectomy 351 2% Subtotal colectomy 787 5% Proctocolectomy 132 1% High anterior resection (1.1-15) 3,827 27% Transverse colectomy 154 1% Laparotomy only 29 % Other 189 1% TOTAL 14,362 1% THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 45

FIGURE 26. OPERATIVE APPROACH OVER TIME FOR COLON CANCER 1 9 8 PERCENTAGE OF OPERATIONS 7 6 5 4 3 2 1 27 28 29 21 211 212 213 214 215 216 217 YEAR Open Minimally Invasive FIGURE 27. RELATIVE FREQUENCY OF SURGICAL COMPLICATIONS FOR COLON CANCER 1 Surgical Complications following Colon Surgery (mean 2.2%) 8 RELATIVE FREQUENCY OF COMPLICATIONS 6 4 AY AX BH BQ BK DI CL DO AQ CS BB BN BF 2 CH CZ BXBE AJ DG CR BY BV BS AZ M BP AW L 5 1, 1,5 NUMBER OF SURGERIES 46 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

TABLE 16. SURGICAL AND MEDICAL COMPLICATIONS FOR PATIENTS UNDERGOING COLON CANCER SURGERY Complication Count Percentage Surgical Complications 2,872 2% Abdominal pelvic collection 262 2% Anastomotic leak 371 3% Entercutaneous fistula 33 <1% Superficial wound dehiscence 214 1% Deep wound dehiscence 76 1% Wound infection 554 4% Sepsis 274 2% Prolonged ileus 1,232 9% Small bowel obstruction 125 1% Urinary retention 179 1% Ureteric injury 15 <1% Splenectomy 19 <1% Postoperative haemorrhage 156 1% Other surgical complications 486 3% Medical Complications 2,278 16% DVT PE 115 1% Chest infection 674 5% Cardiac 752 5% Other medical complications 1,147 8% THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 47

TABLE 17. TUMOUR STAGE FOR COLON CANCER Overall Stage Count Percentage Stage 578 4% FIGURE 28. TUMOUR STAGE FOR COLON CANCER Stage IV (1,569) Stage X (4) Stage (578) Stage I 2,674 2% Stage I (2,674) Stage II 4,469 34% Stage III 3,841 29% Stage III (3,841) Stage IV 1,569 12% Stage X 4 <1% Stage II (4,469) TOTAL 13,171 1% FIGURE 29. MEAN NUMBER OF LYMPH NODES (LN) EXAMINED IN RESECTED SPECIMEN BY HOSPITAL 4 Mean Nodes per Colonic Resection (mean 17.5) 3 DB BZ BE NUMBER OF LN 2 1 CN CJ BD AG BH CB BB AAF CP CG CD CL BK BG R T BS P BO AZ BR BX CH CS DA CU DI CK DO CVCY H K S BU BN BP CT 5 1, 1,5 NUMBER OF SURGERIES 48 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

FIGURE 3. LYMPH NODES EXAMINED IN RESECTED SPECIMEN FOR COLON CANCERS OVER TIME 4 35 3 NUMBER OF LN EXAMINED 25 2 15 1 5 27 28 29 21 211 212 213 214 215 216 217 YEAR THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 49

RECTAL CANCER Management of rectal cancer is frequently more complex than colon cancer. Neoadjuvant therapy is required in a proportion of cases and it is important that patients undergo appropriate preoperative staging and management discussion in a Multidisciplinary Team meeting (MDT) to optimise care outcome. The proportion of rectal cancer cases discussed at an MDT has increased from 51% in 215 to 68% in 216 and now 71% in 217 14,15. Magnetic Resonance Imaging (MRI) application for preoperative staging has increased from 25% in 27 to nearly 8% in 217. There have been a high proportion of cases staged with MRI since 29, which is likely to be secondary to changes in the Pharmaceutical Benefits System (PBS) when MRI staging for rectal cancer was listed on the PBS. Pelvic MRI would now be considered standard of care for rectal cancer staging for all tumours other than very early stage cancers. In early stage cancers being considered for local excision it is useful to help assess the lymph node status. Just over half the patients with rectal cancer have received neoadjuvant therapy, the majority receiving long course chemoradiotherapy. End stoma rate can be a marker of quality of care in rectal cancer surgery. A proportion of patients will require an end stoma as it will not be possible to curatively resect their rectal tumour. However, there are a range of surgical techniques to facilitate reanastomosis and minimise the requirement for a permanent stoma. The end stoma rate was 23% with either an abdominoperineal resection in 19% or a Hartmann s procedure in the remaining cases. There is a spectrum of frequency across units, with a reduction in frequency in units with greater numbers of cases reported. The surgical approach to rectal cancer resection continues to evolve. The proportion of rectal cancers resected with open resection is 34% in 217 which is small decrease from 216. There is a small increase in the proportion of laparoscopic resections. The number of hybrid procedures are the same as 216, and the number of alternative minimally invasive approaches such as tatme are small but with a slight increase. Alterations in practice seem to have stabilised after the potential concern that a laparoscopic approach may not be optimal in a proportion of rectal cancers following the publication of the North-American Z651 2 trial and the Australasian ALaCaRT rectal cancer trial 3. Circumferential Resection Margin (CRM) is an important marker of quality of surgery, as CRM involvement is strongly associated with an increase in local tumour recurrence. The rate of CRM involvement reported is respectable at 7% and has slowly reduced since 27, plateauing over the last 6 years. Whilst the aim is to minimise CRM involvement, a proportion of tumours will have an involved CRM due to the presenting stage of the tumour. These patients should be identified preoperatively, usually through MRI, and subsequently receive preoperative neoadjuvant chemoradiotherapy as this can downstage the tumour, reducing the risk of CRM involvement. The proportion of patients with an involved CRM who have and who have not received neoadjuvant therapy is similar at around 9% and 6% respectively. The desired target would be that all patients with an involved CRM should have received preoperative neoadjuvant therapy. The overall rectal cancer surgical complication rate is 31.3%. It is usual for the complication rate for rectal cancer surgery to be higher than that of colonic surgery, due to the challenges of operating in the pelvis. There is a spectrum in complication rates across the different hospitals. The overall anastomotic leak rate of 3.4% would generally be considered commendably low 4. TABLE 18. PROPORTION OF RECTAL CANCER CASES DISCUSSED AT MDT FOR ALL BCCA DATA* Discussed at MDT Count Percentage Yes 2,811 71% No 1,82 27% Unknown 52 1% Total 3,945 34% *This covers all rectal cancer cases entered into the BCCA where MDT presentation has been reported. 5 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

FIGURE 31. PROPORTION OF PATIENTS WITH RECTAL CANCER UNDERGOING MRI SCAN AS PART OF PREOPERATIVE STAGING OVER TIME 1 9 8 PERCENTAGE OF OPERATIONS 7 6 5 4 3 2 1 27 28 29 21 211 212 213 214 215 216 217 YEAR Yes MRI Staging No MRI Staging TABLE 19. USE OF NEOADJUVANT THERAPY FOR RECTAL CANCER FOR ALL BCCA DATA Count Percentage FIGURE 32. NEOADJUVANT THERAPY USE FOR RECTAL CANCER AND TYPE OF THERAPY* Other (98) 3.5% Neoadjuvant Therapy Received 2,88 49% Neoadjuvant Therapy Not Received 2,87 51% Short Course Radiotherapy (495) 17.6% TOTAL 5,678 1% Long Course Chemoradiotherapy (2,224) 79.% *n=2,817 patients THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 51

TABLE 2. PRIMARY PROCEDURE FOR PATIENTS WITH RECTAL CANCER Operation Count Percentage Proctocolectomy 14 2% High anterior resection (1.1-15) 195 3% Low anterior resection (6.1-1) 1,147 17% Ultra low anterior resection (-6) 2,947 44% APR 1,282 19% Hartmanns 241 4% Miscellaneous operation (eg. for complication) 17 <1% Colo-anal anastomosis 67 1% Local excision 35 5% TEMS/TAMIS 199 3% Laparotomy only 17 <1% Other 176 3% TOTAL 6,697 1% FIGURE 33. DETAILED OPERATIVE APPROACH OVER TIME FOR RECTAL CANCER 1 9 8 PERCENTAGE OF OPERATIONS 7 6 5 4 3 2 1 27 28 29 21 211 212 213 214 215 216 217 YEAR Open Laparoscopic Hybrid Conversion of Laparoscopic Robotic Transanal TaTME 52 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

FIGURE 34. PERMANENT END STOMA RATE BY HOSPITAL FOR RECTAL CANCER PATIENTS 1 RELATIVE FREQUENCY OF PERMANENT END STOMA FORMATION 8 6 4 2 CP CA DE DO AQ CS BG BH BB AJ AZ BS CT AW BF End Stoma formation in Patients with Rectal Cancer (mean 2.6%) BC L AS 2 4 6 8 NUMBER OF SURGERIES TABLE 21. CIRCUMFERENTIAL MARGIN INVOLVEMENT OVER TIME 27 28 29 21 211 212 213 214 215 216 217 TOTAL Negative (>1mm) 114 294 283 395 396 342 311 636 661 666 526 4,624 Positive ( 1mm)(%) 18(11) 21(6) 26(7) 48(1) 32(6) 4(9) 25(7) 48(7) 5(7) 43(6) 34(6) 385(7) Not reported 26 34 53 59 96 64 48 4 3 33 31 514 TOTAL 158 349 362 52 524 446 384 724 741 742 62 5,534 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 53

FIGURE 35. CIRCUMFERENTIAL MARGIN INVOLVEMENT OVER TIME IN RECTAL CANCER 1 9 8 PERCENTAGE OF OPERATIONS 7 6 5 4 3 2 1 27 28 29 21 211 212 213 214 215 216 217 YEAR Negative (>1mm) (Positive 1mm) Not Reported TABLE 22. USE OF NEOADJUVANT THERAPY AND MARGIN INVOLVEMENT Neoadjuvant Therapy Received Neoadjuvant Therapy Not Received TOTAL Count % Count % Count % Negative (>1mm) 2,25 83 1,976 82 4,1 82 Positive ( 1mm) 29 9 142 6 351 7 Not reported 27 8 298 12 55 1 TOTAL 2,441 1 2,416 1 4,857 1 54 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

FIGURE 36. PATIENTS WITH POSITIVE MARGINS AND NEOADJUVANT THERAPY OVER TIME* 1 9 8 PERCENTAGE OF OPERATIONS 7 6 5 4 3 2 1 27 28 29 21 211 212 213 214 215 216 217 YEAR Neoadjuvant Therapy Received Neoadjuvant Therapy Not Received *n=4,496 patients TABLE 23. SURGICAL AND MEDICAL COMPLICATIONS OF PATIENTS UNDERGOING SURGERY FOR RECTAL CANCER Complication Count Percentage Surgical Complications 1,821 27% Abdominal pelvic collection 279 4% Anastomotic leak 189 3% Entercutaneous fistula 13 % Superficial wound dehiscence 174 3% Deep wound dehiscence 66 1% Wound infection 279 4% Sepsis 161 2% Prolonged ileus 661 1% Small bowel obstruction 119 2% Urinary retention 257 4% Ureteric injury 28 <1% Splenectomy 7 <1% Postoperative haemorrhage 76 1% Other surgical complications 367 5% Medical Complications 861 13% DVT PE 5 1% Chest infection 23 3% Cardiac 237 4% Other medical complications 488 7% THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 55

FIGURE 37. SURGICAL COMPLICATIONS IN RECTAL CANCER BY HOSPITAL 1 Surgical Complications following Rectal Surgery (mean 31.3%) RELATIVE FREQUENCY OF OF SURGICAL COMPLICATIONS 8 6 4 2 AC AY CL BW BQ BK CS BH BB AJ BV O AZ BP BS CU CR CJ CX BN M BF L 2 4 6 NUMBER OF SURGERIES 56 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

ADJUVANT THERAPY Adjuvant therapy with chemotherapy is an important component of the management of patients with colorectal cancer. It is not required in all patients but would usually be recommended in patients with Stage III disease and in patients with high risk Stage II disease, following resection of the tumour. The decision over whether to recommend chemotherapy is influenced significantly by the relative fitness and co-morbidities of the patient, which is often affected by the age of the patient. The utilisation of adjuvant therapy is high across Stage III patients of all ages, only reducing in patients aged over 8 years. The uptake is lower is Stage II disease as would be expected, however it is higher in patients under 5 years, reducing proportionately with increasing age. TABLE 24. PERCENTAGE OF STAGE II AND III CANCER PATIENTS RECEIVING CHEMOTHERAPY* Stage Age <3 3-39 4-49 5-59 6-69 7-79 8-89 9+ Total Stage II %Chemo Received 5% 54% 54% 36% 27% 14% 3% 2% 18% Stage III %Chemo Received 91% 95% 92% 87% 85% 74% 33% 6% 71% *n=1,795 treatment episodes FIGURE 38. PERCENTAGE OF STAGE II AND STAGE III PATIENTS WHO RECEIVED CHEMOTHERAPY 1 PERCENTAGE OF PATIENTS RECEIVING CHEMO 9 8 7 6 5 4 3 2 Stage II Stage III 1 <3 3-39 4-49 5-59 6-69 7-79 8-89 9+ CANCER STAGE THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 57

FUTURE DIRECTIONS BCCA UPTAKE Increasing the penetration of the BCCA with the target of recruitment of all surgical colorectal cancer cases remains one of the major aims of the BCCA. The introduction of the electronic template has facilitated access to a number of historic datasets that were previously inaccessible. The uptake of the BCCA by the ANZTBCRS units across Australia and New Zealand will also significantly increase the recruitment of patients on a yearly basis. There will also be a further push to raise the profile of the BCCA to all surgeons who manage colorectal cancer and to emphasise the value of participation. QUALITY IMPROVEMENT Quality improvement and patient safety is a key aim of the BCCA and the intent is to improve the feedback to the participating units. Currently each unit or participating surgeon can obtain instant feedback on their performance with respect to the rest of the database. The BCCA will be expanding the quality reports, having undertaken a pilot program with the ANZTCBRS units. Individualised risk stratified data will be returned to each unit on an annual basis. The data provided will be based on the previously identified KPIs. This will require the unit to have submitted a minimum number of cases to the dataset to allow for appropriate risk stratification. RESEARCH The BCCA has significant potential as a platform for research, particularly health services research. The research governance structure was defined in 216 and all participants of the BCCA are now able to access data for research (following review and approval of a submitted research proposal). The number of submitted research projects has increased and these have started to result in high impact peer reviewed publications. The aim will be to increase this process. SURVIVAL INFORMATION Date and cause of death information is often difficult for surgeons to identify due to a variety of factors including patients relocating, changing care providers and being lost to follow-up. Linkage to existing state or national registries will allow BCCA to access this information and accurately report survival information. 58 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

BCCA PARTICIPATION Participation in BCCA requires approval from the relevant hospital or health service Human Research Ethics Committee (HREC). The requirements vary from country to country, state to state and public vs. private. Support with ethics applications can be offered by the BCCA Project Manager and for further details about your site please contact the Project Manager directly. Approvals must be up to date for the online model. AUSTRALIA PUBLIC ACT* Ethics approval via ACT Health HREC. NSW* Ethics approval via Sydney Local Health District HREC and site-specific governance approval via the applying hospital s Research Governance Officer. NT Ethics approval via Menzies School of Health Research. QLD* - Ethics approval via Metro South Health HREC, Public Health Act approval via QLD Department of Health and site-specific governance approval via the applying hospital s Research Governance Officer. SA* - Ethics approval via Royal Adelaide Hospital HREC and site-specific governance approval via the applying hospital s Research Governance Officer. TAS Ethics approval via the University of Tasmania s Health and Medical HREC. VIC* - Ethics approval via Melbourne Health HREC and site-specific governance approval via the applying hospital s Research Governance Officer. WA* - Ethics approval via Melbourne Health HREC and site-specific governance approval via the applying hospital s Research Governance Officer. *In October 217, BCCA received ethics approval via Melbourne Health HREC under the National Mutual Acceptance (NMA) model of ethics review. This model of review provides ethics approval for all participating hospitals in ACT, NSW, QLD, SA, VIC and WA, with sitespecific governance approvals continuing to be reviewed by the applying hospital s Research Governance Officer. The existing approvals for hospitals participating in the NMA framework are currently being transferred to the Melbourne Health HREC approval. Once all participating sites have successfully been transitioned to the NMA review, existing state-wide HREC approvals will be closed. It is envisioned that this will reduce the ongoing administration requirements for running such a large registry. PRIVATE Each hospital is different; some offer national or state approval, others are approved via Medical Advisory Committee (MAC) and Hospital Executive, while others require an external ethics committee s approval. NEW ZEALAND PUBLIC All public hospitals approvals are in place via Ministry of Health, Health and Disability Ethics Committees (HDEC). PRIVATE Each hospital is different; some offer national approval, others are approved via Medical Advisory Committee (MAC) and Hospital Executive. Once relevant ethical approvals are in place the BCCA Project Manager can create individual surgeon s Consultant accounts. These are linked to their email address where the surgeon can control their password. A surgeon can have several different hospitals linked to their account and when logged in can view all of their submitted data. Other accounts that are available are Site Manager and Data Entry. The Site Manager profile can view and edit data for all surgeons registered at that site and can run all reports available. The Data Entry profile can view and edit data for all surgeons at their site but cannot run all reports. Site Manager and Data Entry accounts can only be linked to one site. Like the Consultant account the password is managed via the linked email address. THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 59

BCCA PERSONNEL BCCA STEERING COMMITTEE Mr Andrew Hunter (Chair) Mr James Keck (CSSANZ) Mr Ian Faragher (Colon and Rectal Surgery Section, RACS) Mr Trevor Collinson (GSA) Mr Grant Coulter (NZAGS) Professor John Zalcberg (Interested Clinician) Mr John Stubbs (Consumer Representative) Professor Alexander Heriot (Chair BCCA Operations Committee) BCCA OPERATIONS COMMITTEE Professor Alexander Heriot (Chair) Professor Christopher Reid (DEPM) Ms Angela Brennan (DEPM) Associate Professor Paul McMurrick (CRC Audit) Associate Professor Chris Byrne Professor Pierre Chapuis Dr Mark Doudle Dr Elizabeth Murphy Professor Cameron Platell Associate Professor Mark Thompson-Fawcett BCCA STAFF Ms Michaela O Regan BCCA Project Manager Suite 6, 9 Church Street Hawthorn VIC 3122 Phone: +61 3 9853 813 Email: bcca@cssanz.org Website: bcca.registry.org.au 6 THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218

GLOSSARY ACCORD - the Australian Comprehensive Cancer Outcomes and Research Database ACPGBI - The Association of Coloproctology of Great Britain and Ireland AJCC American Joint Committee on Cancer ANZTBCRS Australian and New Zealand Training Board in Colorectal Surgery APR Abdominoperineal Resection ASA - American Society of Anaesthesiologists Classification ASCRS - American Society of Colon and Rectal Surgeons BCCA Bi-National Colorectal Cancer Audit CDMS Clinical Data Management Systems CPD Continuing Professional Development CQC Clinical Quality Committee CQR Clinical Quality Registry CRC Audit Colorectal Cancer Audit (Extended dataset managed by Associate Professor Paul McMurrick via Cabrini Institute) CRM - Circumferential Resection Margin CSSANZ Colorectal Surgical Society of Australia and New Zealand DEPM Department of Epidemiology and Preventative Medicine, Monash University DVT PE - Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) ERAS Enhanced Recovery after Surgery FOBT Faecal Occult Blood Test GSA General Surgeons Australia HDEC Health and Disability Ethics Committee HREC Human Research and Ethics Committee ICMJE the International Committee of Medical Journal Editors IQR - Interquartile range, a measure of data variability which is equal to the difference between the third and first quartiles. LN Lymph Nodes LOS Length of Stay MAC Medical Advisory Committee MDT Multidisciplinary Team meeting MRI - Magnetic Resonance Imaging NBCSP National Bowel Cancer Screening Program NBSP National Bowel Screening Programme NMA National Mutual Acceptance (a scheme in Australia of single ethical review of multi-centre clinical trials conducted in each participating jurisdiction s public health organisations) NZAGS New Zealand Association of General Surgeons PBS Pharmaceutical Benefits Scheme RACS Royal Australasian College of Surgeons SJOG Saint John of God SD Standard Deviation SPHPM School of Public Health and Preventive Medicine (Monash University) TAMIS Transanal Minimally Invasive Surgery tatme transanal Total Mesorectal Excision TE Treatment Episode, one treatment episode can include no, one or more than one surgical procedures TEMS Transanal Endoscopic Micro-surgery UK United Kingdom WDHB Waitemata District Health Board THE BI-NATIONAL COLORECTAL CANCER AUDIT REPORT 218 61

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